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The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable restorations retained by endosseous implants to restore masticatory function for the patient.

The LOCATOR Angled Abutment consists of various height abutments with identical attachment features compared to LOCATOR Abutments of the LOCATOR Implant Attachment System, cleared in K072878. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the predicate device of K233587. The LOCATOR Angled Abutments are manufactured from titanium (Ti-6Al-4V) and are titanium nitride (TiN) coated, identical to the predicate device.

The LOCATOR Angled Abutment is indicated for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants to restore masticatory function for the patient.

The LOCATOR Angled Abutment is designed to be used with LOCATOR FIXED and LOCATOR Attachment Systems for the attachment of full or partial, fixed and removable, restorations retained by endosseous implants in the mandible or maxilla. The LOCATOR Angled Abutment consists of various height abutment bodies with an integrated abutment screw. The attachment features are identical compared to LOCATOR Abutments of the LOCATOR High Retention Attachment System (LOCATOR FIXED), cleared in K213391. The LOCATOR Angled Abutment is compatible with Straumann BLX Implant System cleared in K173961. The LOCATOR Angled Abutment will be used with the accessories of the LOCATOR Implant Attachment System (retention inserts, denture attachment housing, and ancillary processing parts) and LOCATOR FIXED Attachment System (fixed inserts, denture attachment housing) for the attachment of a restoration. The LOCATOR Angled Abutment uses identical attachment features as the LOCATOR Abutments, but instead of the attachment features being aligned coaxially, the interfacing features are provided at a 15 degree angle to allow for angle correction, substantially equivalent to the device of K190040. The LOCATOR Angled Abutments and integrated abutment screw are manufactured from titanium (Ti-6Al-4V). The LOCATOR Angled Abutment body is titanium nitride (TiN) coated, identical to LOCATOR Abutments.

The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system. The High Retention Attachment System is compatible with the following implants: (list of compatible implants and diameters provided in the document).

The High Retention Attachment System is a system that provides rigid connection of fixed, partial, and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. It consists of abutments, attachment housings, inserts and seating and removal tools. The abutments are provided in various cuff heights with the implant and abutment connection specific to the Zest Anchors, LLC or OEM implant. The subject device abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated. The High Retention Attachment System is as provided with an abutment (LOCATOR Attachment) and the surgical instrumentation necessary to place the implant. The High Retention Attachment System is designed to accommodate a path of insertion diverqence of up to 20° per implant and no more than 40° of divergence between implants.

The High Retention Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. It is used in fixed hybrid restorations that can be attached with a snap-in system.

The High Retention Attachment System is a system that provides rigid connection of fixed partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. It is designed to accommodate a path of insertion on implants to accommodate a divergence of up to 20° per implant and no more than 40° of divergence between implants. The components are similar to the LOCATOR Implant Anchor Abutment, cleared in K072878; however, the retention and removal of the inserts is similar to that of the LOCATOR F-Tx Attachment System cleared in K151789. The High Retention Attachment System consists of abutment housings, inserts, laboratory processing tools and seating and removal tools. Abutments, attachment housings and inserts are Class II subject devices (Product Code NHA) and laboratory processing tools and seating and removal tools are Class I accessories (Product Code NDP). The abutments are provided in various cuff heights with the implant/abutment connection specific to the OEM implant. The subject device abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) and are TiN (titanium nitride) coated.

TurboTemp EZ is a is a self-cure crown-and-bridge composite indicated for the fabrication of long- and short-term provisional restorations including veneers, inlays/onlays, crowns, bridges and long-span bridges. TurboTemp EZ is also indicated for incorporation of most mechanically anchored attachment components into the acrylic base of a denture, an overdenture, or a partial denture.

TurboTemp EZ is a provisional resin based material intended to be used for the fabrication of crowns, bridges, inlays, onlays, and veneers. The composite material is provided in a dual-barrel cartridge that when combined in the mixing tip, it is dispensed as a self-curing restorative material.

The LOCATOR® F-Tx Attachment System is designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restory function. It is used in fixed hybrid restorations that can be attached with a snap-in system. The LOCATOR® F-Tx Attachment System is compatible with the following implants: Implant Manufacturer Connection Type / Platform | Astra Tech | OsseoSpeed Plus EV: 3.6, 4.2, 4.8 mm | |---------------|---------------------------------------------------------------------| | BioHorizons | Internal Hex: 3.0, 3.5, 4.5, 5.7 mm | | Biomet 3i | Osseotite ® Certain ® : 3.4, 4.1, 5.0, 6.0 mm | | Camlog | Camlog, Conelog: 3.3, 3.8, 4.3, 5.0 mm | | | iSy: 3.8, 4.4, 5.0 mm | | Dentsply | Ankylos ® : 3.5, 4.5, 5.5, 7.0 mm | | MIS Implants | Internal Hex: 3.75, 4.5 mm | | Nobel Biocare | NobelActive ™ : 3.0, 3.5, 3.9 mm | | | Replace ™ Select: 3.5, 4.3, 5.0, 6.0 mm | | | Brånemark: 3.5, 4.1, 5.1 mm | | Straumann | Bone Level: 3.3, 4.1, 4.8 mm | | | Standard: 4.8, 6.5 mm | | Zimmer | Tapered Screw-Vent ® : 3.5, 4.5, 5.7 mm |

The LOCATOR® F-Tx Attachment System is for rigid connection of fixed, partial and full arch restorations on endosseous dental implants using a snap-in or screw-retained attachment system. The system includes abutments and healing caps. LOCATOR F-Tx abutments are compatible with the implant systems, connection types, and platform sizes listed above, and are provided in various gingival cuff heights ranging from 1 to 6 mm. LOCATOR F-Tx System abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). LOCATOR F-Tx abutments may be provided with an optional coating of either TiCN (titanium carbon nitride) or TiN (titanium nitride). LOCATOR F-Tx System Healing Caps are made of PEEK.

The SATURNO™ Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla. The SODI is used to restore masticatory function for the patient and may be suitable for immediate function if sufficient primary stability of the implant is achieved at the time of placement.

The SATURNO™ Overdenture Implant (SODI) System is a one-piece, self-tapping, threaded, root-form . dental implant with the abutment portion being either straight or angled for overdenture prosthetic attachment. SODI implants are provided in three diameters (2.0, 2.4 and 2.9 mm), three lengths (10, 12. and 14 mm) and two cuff heights (2.0 and 4.0 mm). Each size SODI implant has a 1.8 mm attachment ball and is available with a straight or 200 angled abutment section.

Chairside® Attachment Processing Material is a dual cure (either self or UV light) pink composite used to process attachments in a chairside or laboratory procedure.

Chairside Attachment Processing Material is a composite that is used to secure denture cap attachments into dentures. These attachments are commonly used in conjunction with dental implants to assist in affixing dentures to the wearer. Chairside Attachment Processing Material can be used chairside (to pick up the attachments from the mouth of the patient) or in a laboratory setting (using a model of the patient's mouth).

The LOCATOR® Overdenture Implant System is designed to retain overdentures or partial dentures in the mandible or maxilla.

The LOCATOR® Overdenture Implant (LODI) System comprises a narrow diameter endosseous dental implant (2.4mm or 2.9mm in diameter and 10, 12, 14, or 16 mm in length) and a screw-retained abutment (2.9mm platform with cuff heights of 2 or 4mm). The collar of the 2.4mm diameter implant is flared to a 2.9mm platform to accommodate the 2.9mm abutment. The implant is made of Ti 6Al-4V ELI conforming to ASTM F136 and the abutment is made of Ti 6AI-4V ELI conforming to ASTM B348.